Cleared Traditional

K041749 - SCANDIUS ACL RECONSTRUCTION SYSTEM

K041749 is an FDA 510(k) clearance for SCANDIUS ACL RECONSTRUCTION SYSTEM, manufactured by Scandius Biomedical, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K041749 · Scandius Biomedical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
71d
Days
Class 2
Risk

K041749 is an FDA 510(k) clearance for the SCANDIUS ACL RECONSTRUCTION SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Scandius Biomedical, Inc. (Littleton, US). The FDA issued a Cleared decision on September 8, 2004 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Scandius Biomedical, Inc. devices

FDA 510(k) Submission Details - K041749

510(k) Number K041749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2004
Decision Date September 08, 2004
Days to Decision 71 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 122d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HWC Screw, Fixation, Bone

All 923
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K041749.
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ORTHO-PRO CANNULATED BONE SCREWS
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BIOPRO SUBTALAR IMPLANT
K041936 · Biopro, Inc. · Sep 2004
SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS
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ENDOTINE FOREHEAD TRIPLE DEVICE
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